title: Impaired health status and the effect of pain and fatigue on functioning in clinical trial patients with systemic lupus erythematosus.
abstract: OBJECTIVE
  Our study evaluated the impaired health status of clinical trial patients with systemic lupus erythematosus (SLE) and explored the relationship between changes in fatigue and pain and their effect on overall health status.
  
  
  METHODS
  Pooled treatment and placebo data from a phase Ib clinical trial of adults with moderate/severe SLE were analyzed. Measures included patient-reported Medical Outcome Study Short Form-36 Survey, Version 2 (SF-36v2), Fatigue Severity Scale, and numeric rating scales (NRS) for pain and global health assessment and clinician-reported global assessment of disease activity (MDGA). Disease burden was compared to the US general population. Health status of responders and nonresponders on pain or fatigue were compared.
  
  
  RESULTS
  The sample included 161 patients with SLE, predominantly female (96%) and white (72%), with average age of 43 ± 11 years. Mean SF-36v2 component summary scores reflected overall problems with physical [physical component summary (PCS); 35.2 ± 9.7] and mental health (mental component summary; 40.9 ± 12.9). Patients with SLE had worse health status on all SF-36v2 subscales than the US general population and comparable age and sex norms (effect size -0.51 to -2.15). Pain and fatigue responders had greater improvements on SF-36v2 scores (bodily pain, physical functioning, social functioning, PCS), patient global health assessment NRS, and MDGA than nonresponders. There was moderate agreement in responder status, based on global assessments by patients and clinicians (68.1%), with some discrepancy between patients who were MDGA responders but patient assessment nonresponders (27.7%).
  
  
  CONCLUSIONS
  Improvements in patient-reported pain or fatigue correlated with improvements in overall health. Patient assessments offer a unique perspective on treatment outcomes. Patient-reported outcomes add value in understanding clinical trial treatment benefits.
authors.affiliation: From the Johns Hopkins University School of Medicine, Baltimore, Maryland; United BioSource Corporation, Bethesda, Maryland; and MedImmune LLC, Gaithersburg, Maryland, USA.
authors.forename: Michelle
authors.initials: M
authors.lastname: Petri
authors.forename: Ariane K
authors.initials: AK
authors.lastname: Kawata
authors.forename: Ancilla W
authors.initials: AW
authors.lastname: Fernandes
authors.forename: Kavita
authors.initials: K
authors.lastname: Gajria
authors.forename: Warren
authors.initials: W
authors.lastname: Greth
authors.forename: Asha
authors.initials: A
authors.lastname: Hareendran
authors.forename: Dominique
authors.initials: D
authors.lastname: Ethgen
mesh_terms: D000203:Activities of Daily Living / Q000523:psychology*; D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D002986:Clinical Trials as Topic; D004185:Disability Evaluation; D005221:Fatigue / Q000150:complications* / Q000523:psychology; D005260:Female; D006304:Health Status; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000150:complications* / Q000188:drug therapy / Q000523:psychology; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000150:complications* / Q000523:psychology; D011788:Quality of Life / Q000523:psychology*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C568334:sifalimumab
keywords: FATIGUE; PAIN; QUALITY OF LIFE; SIFALIMUMAB; SYSTEMIC LUPUS ERYTHEMATOSUS